Determinants on Rocuronium Dose for Deep Block in Bariatric Surgery

January 12, 2021 updated by: Seoul National University Bundang Hospital

Analysis of Determinants on the Dose of Rocuronium for Deep Neuromuscular Blockade in Bariatric Surgery.

Find out the deciding factor(total body weight, corrected body weight, ideal body weight, fat-free mass, body mass index, skeletal muscle mass, body fat) of neuromuscular blocker dose for deep neuromuscular blockade in bariatric surgery.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Before the surgery, total body weight, corrected body weight, ideal body weight, fat-free mass, body mass index were measured by height and weight and skeletal muscle mass and body fat were measured by Bioelectrical impedance analysis (InbodyH20B). Find the highest correlation between the 8 factors (total body weight, corrected body weight, ideal body weight, fat-free mass, body mass index, skeletal muscle mass, body fat) and the amount of rocuronium administered to deep neuromuscular blockade in bariatric surgery.

Study Type

Observational

Enrollment (Anticipated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

obese patients who scheduled bariatric surgery

Description

Inclusion Criteria:

  • Patients aged 20-80 and American Society of Anesthesiology Physical Grade (ASA) I-II, who undergo bariatric surgery

Exclusion Criteria:

  • kidney disease (GFR<60)
  • allergy to study drugs
  • decline participation
  • side effect of propofol and remifentanil
  • when anesthesia does not maintain the level of alertness (BIS) below 60 even when the anesthetic dose is increased, or when hemodynamic instability such as bradycardia and hypotension appears

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
obese patients
obese patients underwent bariatric surgery
Drug: deep neuromuscular blockade in bariatric surgery
obese patients who underwent bariatric surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the highest correlation coefficient
Time Frame: preoperative 1 days to postoperative 1 days
the relationship of rocuronium for deep neuromuscular blockade in bariatric surgery and 8 factors (corrected body weight, ideal body weight, lean body weight, fat-free mass, body mass index, skeletal muscle mass, body fat)
preoperative 1 days to postoperative 1 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
onset time of rocuronium
Time Frame: preoperative 1 days to postoperative 1 days
time from injection of rocuronium 0.6 mg/kg(TBW) to TOF ratio is less than 0.05
preoperative 1 days to postoperative 1 days
time to deep neuromuscular blockade
Time Frame: preoperative 1 days to postoperative 1 days
time from injection of rocuronium 0.6 mg/kg(TBW) to PTC 1
preoperative 1 days to postoperative 1 days
Recovery time
Time Frame: preoperative 1 days to postoperative 1 days
time from sugammadex injection to TOF ratio > 0.9
preoperative 1 days to postoperative 1 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2021

Primary Completion (Anticipated)

October 1, 2021

Study Completion (Anticipated)

October 1, 2021

Study Registration Dates

First Submitted

January 12, 2021

First Submitted That Met QC Criteria

January 12, 2021

First Posted (Actual)

January 14, 2021

Study Record Updates

Last Update Posted (Actual)

January 14, 2021

Last Update Submitted That Met QC Criteria

January 12, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • B-2009/639-301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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